8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 12, 2021

CASI PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

delaware (State or other jurisdiction  of incorporation or organization) 0-20713 (Commission File Number)   58-1959440 (IRS Employer Identification No.)

9620 Medical Center Drive, Suite 300

Rockville, Maryland

(Address of principal executive offices)

20850

(Zip Code)

(240) 864-2600

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of exchange on which registered
Common Stock	CASI	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01. Regulation FD Disclosure.

On March 12, 2021, CASI Pharmaceuticals, Inc. delivered a slide presentation via live public webcast in conjunction with an update on recent business developments. A copy of the slide presentation is being furnished as Exhibit 99.1.

The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 hereto shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description of Document
99.1	Slide presentation dated March 12, 2021
104	Cover Page Interactive Data File (embedded within the inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CASI PHARMACEUTICALS, INC.

/s/ Cynthia W. Hu

Cynthia W. Hu

Chief Operating Officer, General Counsel & Secretary

Date: March 12, 2021

EX-99.1

Exhibit 99.1

Corporate Presentation March 2021

Disclaimer This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, strategies, expectations and goals . Forward - looking statements are subject to numerous assumptions, risks and uncertainties, which change over time . Forward - looking statements speak only as of the date they are made, and no duty to update forward - looking statements is assumed . Actual results could differ materially from those currently anticipated due to a number of factors . Such factors, among others, could have a material adverse effect upon our business, results of operations and financial condition . Additional information about the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U . S . Securities and Exchange Commission, including, but not limited to, our Annual Reports on Form 10 - K and our Quarterly Reports on Form 10 - Q, which are available at www . sec . gov . 2

3 • EVOMELA ® launched in China − Strong growth in sales, with 2020 full - year projected revenue of $ 15 million* and project 50 % + growth in 2021 • Initiating regulatory submission and registration studies in China for Thiotepa in 2021 • CNCT 19 : CD 19 CAR - T Cell Therapy − Granted Breakthrough Therapy Designation and on track for 2021 year end China NDA submission • BI - 1206 : Checkpoint Inhibitor Targeting Fc γ RIIB − Phase 1 trial 6 responders (including 2 CR) out of 9 evaluable Non - Hodgkin’s Lymphoma (“NHL”) patients • CID - 103 : Anti - CD 38 mAb − Phase 1 trial site initiation in Q 1 2021 • CB - 5339 : Novel Target VCP/p 97 small molecule inhibitor − Potential for use in broad range of hematologic malignancies and solid tumors − Two active Phase 1 trials in dose escalation CASI - Highlights * The Company’s full year 2020 revenues are preliminary and are subject to the completion of the Company’s 2020 audit. Comple te full year 2020 financial results will be reported in March.

CB - 5339 VCP/P97 Inhibitor Partner: Cleave Therapeutics 4

Novel target - VCP/p97 • VCP is a AAA ATPase enzyme that extracts and unfolds proteins, essential for cancer cell survival • Disruption of DNA damage response and protein homeostasis pathways drive cancer cells to apoptosis • Cancer cells differentially sensitive Lead Product - CB - 5339 • A 2nd generation small molecule inhibitor of VCP/p97 with biochemical potency of 9 nM • ATP - competitive and binds primarily to the D2 ATPase domain of VCP/p97 • Potential for use in broad range of hematologic malignancies and solid tumors • Two active Phase 1 trials in dose escalation • AML/MDS trial sponsored by Cleave Therapeutics • Solid tumors/advanced lymphomas trial sponsored by National Cancer Institute ATP / Inhibitor Binding Sites CB - 5339 - Clinical Stage Asset Inhibiting Novel Target VCP/p97

Misfolded Protein Target for CB - 5083/CB - 5339 Target for Bortezomib and Carfilzomib VCP/p97 Aberrant protein synthesis Endoplasmic Reticulum (ER) Lumen Cytoplasm Proteins Degraded mRNA Poly - Ub Chain Anderson et al. 2015. Cancer Cell Endoplasmic Reticulum Association Degradation (ERAD) • Critical to protein homeostasis • Extraction of proteins for proteasomal degradation • Inhibition causes irresolvable proteotoxic stress driving cancer cell death in solid tumors and MM indications • Potential to combine well with multiple myeloma agents and others in the unfolded protein response VCP/p97 Inhibition Plays a Key Role Regulating Protein Degradation and Drives Cytotoxic Buildup of Proteins in the Endoplasmic Reticulum 6

• DNA damaging agents, such as 7+3, are standard of care in AML – but patients develop resistance due to upregulation of DNA damage response proteins 1 • VCP/p97 plays a key role in this response - involved in chromatin remodeling as well as extraction / turnover of DDR proteins 2 - 4 • Impairment of VCP/p97 activity induces chromatin stress, reduces double strand break (DSB) repair and cell survival after ionizing radiation2 • Mechanistic studies validate VCP/p97 role in DNA damage repair in AML and translates to efficacy in vivo and in vitro5 • VCP/p97 activity crucial for regulation of RNF8 at DSBs, which is critical for 53BP1 recruitment to DNA damage6 1 Bao et al., 2006, Oliver et al., 2010, Bobola et al., 2012, 2 Torrecilla et al. 2016. Phil. Trans. R. Soc. Biol; van den Boom et al 2016. Molecular Cell; 3 Vaz et al. 2013. Front. Genet. 4 Acs et al. 2011. Nat Struc Mol Biol; 5 Benajiba et al. 2017. Blood 130:880; http://www.bloodjournal.org/content/130/Suppl_1/880 , Benajiba et al. ASH 2020, 6 Singh et al. 2019. EMBO Journal. Evolving Understanding - Unique Role for VCP/p97 in the DNA Damage Response (DDR) With Exquisite AML Sensitivity 7

VCP/p97 is an Attractive Broad Oncology Target • Cleave’s agent, CB - 5339, has impressive efficacy across a broad panel of cancer cell lines with IC 50 s in the sub - 100nM for the most sensitive lines • Hematologic malignancies such as AML and multiple myeloma rank as some of the most sensitive across multiple experiments • Solid tumors with high levels of protein turnover such as pancreatic and neuroendocrine also have high sensitivity A M O 1 L P - 1 H 2 3 4 7 M e W o H 2 0 3 0 R P M I 8 2 2 6 H 2 1 2 2 R a m o s ( R A 1 ) M V - 4 - 1 1 H 7 1 6 M I A P a C a S J S A 1 L - 3 6 3 D a u d i S K - M E L - 5 C 2 B B e 1 B x P C - 3 H T - 1 0 8 0 A 1 0 1 D R a j i M S T O - 2 1 1 H H 5 2 6 C 3 2 U 2 6 6 B 1 H 1 9 7 5 B I C R 1 8 M K N 4 5 H C C 1 9 5 4 O P M - 2 H 1 7 0 3 A 2 0 5 8 H 1 9 4 4 M a l m e - 3 M H 1 3 5 5 A - 2 5 3 C O L O 8 2 9 H 2 1 2 6 A 5 4 9 S K - H E P - 1 D L D 1 C O L O 6 6 8 L C - 2 / a d M D A - M B 4 3 5 S K - M E L - 1 C F P A C - 1 B I C R 1 6 L o V o S K - U T - 1 S K - N - D Z H 1 6 5 0 L S 5 1 3 S W 9 4 8 H 2 2 2 8 S K - N - F I S N U - 4 4 9 H T - 2 9 H 6 4 7 C H L - 1 H 2 0 9 H 4 4 1 S N U - C 1 H L F - a H 2 8 H C C 1 9 3 7 S N U - 4 7 5 H 1 6 9 3 H 1 7 7 0 H 1 0 9 2 S K - O V - 3 0.01 0.1 1 10 cancer cell lines 7 2 h r s C B - 5 3 3 9 E C 5 0 ( µ M ) 100 nM – 1 µM 138 Cancer Cell Lines Cytotoxic Activity Across Broad Panels of Cancer Cell Lines Wellcome Sanger Institute Cancer Dependency Map Project; Behan et al Nature 2019; Cleave internal data 8

Accelerated Titration 3 + 3 Escalation Monotherapy Dose Expansion R/R AML at RP2D Monotherapy Dose Expansion Int./Higher Risk MDS • CB - 5339 dosed orally QD on days 1 - 4 each week • 28 - day cycles and DLT window • Intrapatient escalation permitted • Study open at sites in the US and Australia Open to R/R AML/MDS and Myeloid Malignancies Combination R/R AML at RP2D Combination Int./Higher Risk MDS • Favorable safety profile to date through multiple dose escalation cohorts • Data to date supports achieving therapeutic exposure without the off target visual toxicity that halted development of Cleave’s first - generation VCP/p97 inhibitor (CB - 5083) Cleave CB - 5339 Phase 1 Study Focused on AML/MDS 9

CAD / DDR Disruption DNA Damage Accumulation Genotoxic Stress VCP Inhibition Cellular Apoptosis CB - 5339 demonstrates strong activity in AML cell lines • VCP/p97 has an emerging role in chromatin associated degradation and the DNA damage response (DDR) that can be leveraged to drive genomic stress and cytotoxicity in cancer. Scientific Rationale for CB - 5339 in Acute Myeloid Leukemia 10

Clinical Assets China Developed Innovative Cell Therapy with Co - Commercialization Rights Investigational Innovative Drug Candidate In - Licensed for Greater China Region Investigational Innovative Drug Candidate with Global IP and Commercial Rights U.S. FDA - Approved Products In - Licensed for Greater China Region CNTC19 (Autologous anti - CD19 T - cell therapy) 1 Indication Indication Indication Indication CTA Filing & Review Phase 1 Phase 2 Registration Trial NDA Filing & Review CTA Filing & Review Phase 2 Registration Trial NDA Filing & Review Pre - Clinical IND / IMDP Phase 1 Phase 2 Phase 3 Pre - Clinical IND / IMDP Phase 1 Phase 2 Phase 3 Non - Hodgkin’s Lymphoma Acute Lymphoblastic Leukemia (“ALL”) Non - Hodgkin’s Lymphoma 2 Solid Tumors 3 Multiple Myeloma Multiple Myeloma In - Licensed Licensed and Commercially Available in China BI - 1206 (anti - FcyRIIB antibody) CID - 103 (Anti - CD 38 mAb ) EVOMELA Investigational Innovative Drug Candidate In - Licensed for Greater China Region CB - 5339 (VCP/P 97 Inhibitor) Indication Pre - Clinical IND / IMDP Phase 1 Phase 2 Phase 3 AML/MDS 4 Solid Tumors 5 11 (1) Clinical development is the responsibility of Juventas Cell Therapy Ltd. (2) In combination with rituximab. Trial conduct ed by BioInvent . (3) In combination with pembrolizumab. Trial conducted by BioInvent . (4) Trial conducted by Cleave Therapeutics. (5) Trial conducted by National Cancer Institute.

Thank You

XML

Cover	Mar. 12, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 12, 2021
Entity File Number	0-20713
Entity Registrant Name	CASI PHARMACEUTICALS, INC.
Entity Central Index Key	0000895051
Entity Tax Identification Number	58-1959440
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	9620 Medical Center Drive
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Rockville
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20850
City Area Code	240
Local Phone Number	864-2600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	CASI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false